Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
  • A61F5/441—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices having venting or deodorant means, e.g. filters ; having antiseptic means, e.g. bacterial barriers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
  • A61F5/4404—Details or parts
  • A61F5/4405—Valves or valve arrangements specially adapted therefor ; Fluid inlets or outlets
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
  • A61F5/445—Colostomy, ileostomy or urethrostomy devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
  • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
  • A61F5/445—Colostomy, ileostomy or urethrostomy devices
  • A61F5/448—Means for attaching bag to seal ring

Definitions

• the present invention relates to ostomy appliances and more particularly to ostomy pouches having a filter.
• ostomy pouches with or without oleophobic membranes have not addressed the clogging issue as effectively as desired by many ostomates.
• ostomy pouches utilizing multiple membranes to improve both oleophobic and hydrophobic property in the filter, but this design increases the resistance of air flow significantly.
• Most commercial ostomy filters are based on radial flow in which the gases flow along the plane of a relatively flat filter rather than directly or axially through the thickness of the filter. Such a radial or planar flow type is used in order to increase the reaction time between gases and the activated carbon.
• An axial flow type filter is difficult to make because of the difficulties involved in balancing the deodorization efficiency, the air flow requirement, and the profile of the filter.
• a small filter size is preferred because it allows the filter to be positioned as close as possible to the seam of a pouch so that the face of the filter is not directly in front of the opening of the stoma, thus decreasing the tendency of filter clogging.
• One aspect of the invention in the filter design of the present invention is to improve the clogging resistance by using the newly developed pleated center panel design.
• This design includes a filter in the front panel of the pouch and a center panel of film that is intended to shield the filter from direct exposure to stool that is expelled from the stoma.
• the center panel has at least one pleat, and preferably two pleats, that are intentionally formed into the center panel. These pleats allow the gas to travel from the stoma area into the filter area while preventing a majority of the stool from get to and fouling the filter. Without these pleats the center panel has a tendency to block or seal against the front panel of the pouch and not allow gas to get to the filter and thus cause ballooning of the pouch.
• an open cell foam can be added between the face of the filter and the pleats to further reduce any stool that might get past the pleats.
• Another aspect of the invention is the incorporation of a filter designed for axial air flow.
• the pleated design makes possible the use of a small size filter which has a low profile.
• Both the strip filter and axially flow filter can be combined with the pleated center panel design to improve the clogging resistance.
• Another aspect of the invention is a strip filter design, in which the filter is wrapped with an odor barrier film around its perimeter. Such a design allows the filter to maximize its deodorization performance without significantly increasing the air flow resistance.
• a test method was devised to mimic actual usage of filtered pouches and their resistance to clogging. Testing was conducted on a specifically designed tilting table test rig. The test rig was designed to hold the test filtered pouches in the vertical position and tilt them to the horizontal position at timed intervals.
• the tilt table test rig also incorporates a means to inject air into the filtered test pouch to simulate gas produced by the body.
• the test pouches with filters are also filled with a simulated stool referred to as Feclone, which is commercially sold and mixed to a desired viscosity of 1 part solid to 3 parts water, to challenge the filtering system from a clogging perspective.
• Feclone a simulated stool referred to as Feclone
• the filtering system is exposed to the simulated stool and simulated gas at timed intervals of 10 minutes in each position.
• Pouches are continuously cycled through the vertical and horizontal positions during this tilt table test. During each cycle the test pouches are injected with about 300 cc air to fill each pouch every 10 minutes with a fill time of 5 seconds.
• test pouch When the filter is not clogged, the test pouch deflates normally by releasing the air through the filter system. Testing is continued until all pouches have failed to release air from inside of the pouch, as indicated by the ballooning in the pouch.
• the criteria for filter failure is when a test filtered pouch fails to deflate and stays fully ballooned for 3 consecutive tilt table cycles. When ballooning occurs, the simulated stool clogs the filter and the filter system can no longer release the air.
• Table 2 The physical dimension of an axial flow filter versus a radial flow filter is shown in Table 2.
• Table 3 is a summary of the H 2 S deodorization results of the same axial flow filter and the radial flow filter at various relative humidity and with different carrier gases.
• Table 4 is a graph of the results from Table 3. As can be shown from Table 3 and 4, an axially flow filter outperformed the radial flow filter in the H 2 S deodorization even though the activated carbon layer is thinner and the surface area is smaller.
• Table 5 is a summary of the H 2 S deodorization results of a strip filter, in a rectangular dimension 15 mm x 33 mm, versus a round filter with a diameter of 25.4 mm. Although the total surface area and the activated carbon thickness are about the same, the strip filter had significantly higher deodorization time due to the increased effective flow distance. In this example, the effective flow distance is almost 33% longer, resulting in a longer H 2 S deodorization time.
• the present invention includes the following: 1. Pleated center panel that improves clogging resistance.
• An open cell foam can be added to further increase clogging resistance.
• This pleated design, with and without the foam can be used with all types of filters, round or strip, radial flow or axial flow.
• the pleated design, with and without the foam can be used in either drainable or closed pouch.
• Fig. 1 is a rear elevational view of an ostomy appliance in accordance with the present invention.
• Fig. 2 is a cross-sectional view along line A-A of Fig. 1.
• Fig. 3 is a cross-sectional view along line D-D of Fig. 1 (without the stomal flange and filter, for clarity).
• Fig. 4 is a front elevational view of the ostomy appliance of Fig. 1 (without the stomal flange, for clarity). DETAILED DESCRIPTION OF THE DRAWINGS
• the present invention is an ostomy appliance 10 (Figs. 1-4) having a front panel 12 and rear panel 14 that are sealed together around the peripheries of the panels to form the outer edge 16 of a closed ostomy pouch 18.
• the rear panel 14 includes a stomal opening 20 through which body waste is excreted when the ostomy pouch is appropriately placed on a body with the stomal opening 20 surrounding the stoma.
• the ostomy pouch 18 includes a filter assembly 22 attached to the front panel 12 typically by welding.
• the rear panel 14 includes an opening for permitting and facilitating the passage of the body waste odor deodorized by the filter assembly 22 to the atmosphere.
• the ostomy pouch 18 further includes a center pleated panel 28 present between the front panel 12 and rear panel 14.
• This center pleated panel 28 includes an edge 30 attached to the outer edge 16 of the ostomy pouch 18.
• the center pleated panel has a partially free edge portion 32 that is attached intermittently 34 to the inner surface of the front panel 12.
• This center pleated panel 28 is predeterminedly dimensioned and attached to the front panel 12 in a manner to produce extra material in the form of folds, corrugations or pleats 36 within the pouch 18; the pleats 36 permit odorous gas to reach the filter assembly 22 for deodorization while deterring a ballooning of the pouch 18 due to captured gas within the pouch.
• the pleated center panel 28 extends partially down from the top 36 of the ostomy pouch so as to at least partially and preferably totally cover and protect the filter assembly 22 from any body waste material entering the pouch 18 through the stomal opening 20.
• the pleats 36 are formed in part by the spot welds 38 securing the edge portion 32 to the front panel 12.
• the pleated center panel 28 has a bottom edge 40.
• the pleated center panel 28 is preferably made of the same standard ostomy pouch material used for the front panel 12 and rear panel 14. Variations and modifications to the preferred embodiment may be made while falling within the scope of the invention as defined by the claims.

Landscapes

• Health & Medical Sciences (AREA)
• Epidemiology (AREA)
• Nursing (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Orthopedics, Nursing, And Contraception (AREA)

Priority Applications (1)

Applications Claiming Priority (3)

Publications (3)

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Family Applications (1)

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Cited By (1)

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Citations (4)

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• 2011
  • 2011-09-30 CN CN201180057593.XA patent/CN103228236B/zh active Active
  • 2011-09-30 NZ NZ610030A patent/NZ610030A/en not_active IP Right Cessation
  • 2011-09-30 PL PL11829957T patent/PL2621418T3/pl unknown
  • 2011-09-30 WO PCT/US2011/054177 patent/WO2012044910A1/en active Application Filing
  • 2011-09-30 EP EP11829957.7A patent/EP2621418B1/de active Active
  • 2011-09-30 RU RU2013119940/14A patent/RU2593717C2/ru active
  • 2011-09-30 ES ES11829957.7T patent/ES2639889T3/es active Active
  • 2011-09-30 AU AU2011308677A patent/AU2011308677A1/en not_active Abandoned
  • 2011-09-30 MX MX2013003672A patent/MX2013003672A/es unknown
  • 2011-09-30 DK DK11829957.7T patent/DK2621418T3/en active
  • 2011-09-30 JP JP2013531905A patent/JP6235904B2/ja active Active
  • 2011-09-30 BR BR112013007677-1A patent/BR112013007677A2/pt not_active IP Right Cessation
  • 2011-09-30 CA CA2813248A patent/CA2813248C/en not_active Expired - Fee Related
• 2016
  • 2016-09-09 JP JP2016177009A patent/JP6456889B2/ja active Active
  • 2016-11-30 AU AU2016266028A patent/AU2016266028B2/en not_active Ceased
• 2019
  • 2019-01-03 AU AU2019200017A patent/AU2019200017B2/en not_active Ceased
• 2021
  • 2021-11-04 US US17/518,938 patent/US20220054294A1/en not_active Abandoned

Patent Citations (4)

Non-Patent Citations (1)

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